1. Field of the Invention
Impotency is a major problem for millions of men. It is the result of a multitude of problems including circulation deficits from debilitating diseases such as diabetes and cancer, spinal injury, aging, and the adverse cross-effects of medication. Impotency drastically effects and reduces the standard of life of the partners to a marriage, by increasing stress on couples already burdened with ill health and aging.
2. Description of the Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(1) Prior Art
Therapy for impotency has been treated for many years by herbs, drugs and mechanical devices. Numerous types of herbs and prescription drugs apply a systemic chemical stimulation to effect the flow and retention of blood in the penis to effect an erection. Vacuum Erection Devices draw blood into the penis, where it is retained by a constriction device to attain and retain an erection of the penis
(2) Deficiencies in the Art
Herbs and natural remedies have historically not provided a consistent success rate for providing relief from impotence; some herbs can produce dangerous side effects with other herbs and drugs.
Prescription drugs attack the problem by a systemic application of chemicals which are invasive per se; they can negatively interact with other medication, and may be dangerous to use for patients with certain health risks. They are convenient for the patient to use; however the health risk of the use of one such prescribed drug for impotence has been attributed to approximately 200 deaths in its early years of use.
Surgically Implanted Mechanical Devices have provided comfort for men who experience erectile dysfunction; however they are very invasive, they can create permanent tissue damage, and a loss of sensitivity, as well as the risk of surgery per se.
Prior State of the Art Vacuum Erection Devices are awkward for the patient to use, however they are non-evasive and therefore are not life threatening. They have the advantage of not being a systemic application of a therapy which requires of a specifically designed target.
Full advantage of Vacuum Erection Devices concepts have not been refined to fully utilize the anatomy of the penile arteries which are located in the central portion of the penis, and the veinal vessels are located sub-dermally to the penis. Arterial blood flow is induced into the flaccid penis when it is inserted in a vacuum plenum, the a constricting ring, which is essentially a tourniquet, is used to restrain the veinal blood flow from leaving the penis to retain the erection. Differential pressures on the penile arteries, veinal vessels and adjacent tissue must be applied to the penis in such a manner to optimize maximum erection time while maintaining a healthy blood flow control in the penis; provisions also be must be included to eliminate occlusion of seminal ejaculation.
Prior Art has been awkward, and as such patients are reluctant to use it for continued therapy; refining the design of Vacuum Erection Devices give the patient an alternative to avoiding more risky invasive therapy.
Cray, U.S. Pat. No. 3,759,253; makes no claim for urethra clearance to effect ejaculation, and it makes no provision or claims to retain said urethra clearance when the device is stretched and distorted when under tension whereby it loses it's geometric shape when applied to an turgid penis, and thereby loses it effect of clearance for ejaculation relief when it is used as a constricting device to control blood flow in the penis.
Hale, U.S. Pat. No. 5,336,157; is not fully compatible with a Vacuum Erection Device use; it lacks ability to optimally control veinal vessel and penile arteries blood flow; it could produce damage to penile tissue, and be an irritant to partner's vagina and pubic hair.
Kock, U.S. Pat. No. 4,203,432; this device is not capable of being assembled optimally on the penis to be used in conjunction with a Vacuum Erection Device; it makes no claims for urethra clearance obstruction to effect ejaculation; it can produce damage to penile tissue and can be intrusive to partner's vagina and pubic hair.
Yanuck, U.S. Pat. No. 4,753,227; omits claims or provisions for the application of differential pressure to control blood flow to effect an erection; it also omits claims or provisions for ejaculation relief
Yamanaka, U.S. Pat. No. 5,234,401; employs a method to achieve an erection, but omits addressing the problem of adequately retaining the erection, or providing for ejaculation relief.
Osborn, U.S. Pat. No. 5,234,402; is not a workable solution in that the flat disc-like tissue shield is awkward for the patient to apply, and in that it is part of the cincture band it lacks flexibility and mobile ability to conform to the change in size of the flaccid penis without loss of vacuum which is required to effect an erection; it does not address differential pressure requirements between the penile arteries and veinal vessels to control blood flow to produce an optimum erection; and the device's limited function as a cincture band can make it difficult and painful to remove from an engorged penis.
Walsdorf, U.S. Pat. No. 5,344,389; lacks the ability to seal properly without loss of vacuum due to the increase diameter of the penis as it changes from a flaccid state to a turgid state, it does not selectively control penile and veinal blood flow for optimal erection, it does not make provisions for protection of the seminal vesicular tube or urethra of the penis for ejaculatory relief, and it can be awkward for the patient to apply, and painful and difficult to remove from a turgid penis.
Merrill et al, U.S. Pat. No. 5,125,890; does not claim or employ any means of relieving pressure of a stricture on the seminal vesicular tube or urethra of the penis for ejaculation relief; it does not claim or employ any means of creating differential pressure on the erect penis to control or sustain an optimal erection of the penis.
Osborn, U.S. Pat. No. 5,244,453; does not claim or address that the "cincture band" it uses as a tourniquet can or is able to create differential pressure on the penis to control blood flow in the penis, nor does it claim or address solution of occlusion of the seminal urethra tube for ejaculation; it can difficult and painful to remove from a turgid penis.
Baber, U.S. Pat. No. 5,246,015; makes a provision for clearance and avoidance of occlusion of the penile urinary tract; it does not produce required blood flow into the penis, nor does it make adequate provision for differential blood flow in the penis, nor is the design suitable for utilizing Vacuum Erection Devices; it lacks ability to conform to the growth of the diameter of the penis because of the integral combination of the "annular rim" and the "tubular portion", it lacks stability and could be a irritant to the user and his sex partner, in that "Should the device slide forward . . . the thrust from the sex act will force the device . . . back to its proper position", the device's ability to correct an impotence problem is less than marginal at best, as it's application to a flaccid penis as claimed, acts as a deterrent to the infusion of needed blood into the penis which is required for it's erection; in the event a erection could be achieved while the device encircled the penis, the device could produce difficulty and pain of it's removal from a turgid penis.
Osborn U.S. Pat. No. 5,306,227; cannot retain its geometric shape when it is stretched to go over an erect penis; therefore any groove or channel designed to provide urethra clearance to protect for urethra occlusion which exists in it's geometry in a state of rest disappear and is non-functional and becomes moot in it's intended to the role as a tourniquet to restrict from flow when stretched and applied to an erect penis; no claim or provision is made for selective differential pressure of the retaining ring on an erect penis to optimize blood flow to extend duration of user's wear or counteract diminished temperature gradients in the penis.
Finkle, U.S. Pat. No. 5,338,288; is an effective primitive tourniquet which does not claim or provide for differential control of blood flow in an erect penis, nor eliminate occlusion to the urethra for seminal ejaculation; it could be difficult and painful to remove from a turgid penis by the patient.
Collins, U.S. Pat. No. 5,370,601; does not claim or employ a means of inducing blood flow into the penis to create an erection, no claim or means are addressed to creating or maintaining a differential blood flow control in the penis, and no provision is made for occlusion of the urethra in the device, it could be extremely difficult and painful for the patient to remove it from a turgid penis.
Chaney, U.S. Pat. No. 5,695,444; does not employ a vacuum device and lacks the ability to bring significant blood flow into the penis to achieve an acceptable erection; it could be non-functional on most patients exhibiting significant erectile dysfunction; it could be extremely difficult to apply over the genitals and scrotum, and even more difficult to remove from the genitals with an erect penis making it unsuitable for many patients.
McCarty, U.S. Pat. No. 5,647,837; is a significant advancement, in that it creates a vacuum seal on the flaccid penis, and maintains said seal while the penis achieves it erectile state, so that no vacuum loss occurs and the erection is not compromised in applying a constriction device for blood flow control; but the invention does not address differential pressure points or urethra clearance for ejaculation.
McCarty, application Ser. No. 08/647,576 is a continuation in part of U.S. Pat. No. 5,647,837; it addresses urethra clearance for ejaculation, but dose not address differential pressure points for specific blood flow control.